LAUSR

Background and aims Fluvoxamine can markedly increase the serum melatonin level, which regulates human circadian rhythm. However, only limited research has evaluated the effects of fluvoxamine on sleep architecture. Thus, the current study aims to investigate the effect of fluvoxamine on PSG characteristics and the impact of persistent insomnia on the prognosis of depression in the depressed individual with insomnia over the course of 8 weeks. Methods Thirty-one clinically depressed patients with insomnia were enrolled in this 8-week, open-label, baseline-controlled study, and 23 patients completed the study. All participants were assigned to receive fluvoxamine for 8 weeks. They were assessed by the PSG, Hamilton Rating Scale for Depression (17 items) (HRSD-17), Clinical Global Index, Pittsburgh Sleep Quality Index, and Epworth Sleepiness Scale at baseline and the following visits, which were at day 14, day 28, and day 56. A patient with an ≥4 HRSD-17 sleep disturbance factor score at both baseline and endpoint (day 56) was defined as a patient with persistent insomnia. Results Compared with baseline, the percentage of stage 3 sleep had significantly (F=11.630, P=0.001) increased in all 3 visits. Moreover, the percentage of rapid eye movement sleep was reduced during the study, with only a significant difference (F=3.991, P=0.027) between baseline and day 14. Finally, 47.8% (11/23) of the participants were in remission, and 60.9% (14/23) of them did not report insomnia. The clinical remission ratio of the persistent insomnia group (11.1% [1/9]) (χ2=8.811, P=0.004) was significantly lower than that of the non-insomnia group (71.4% [10/14]) at the endpoint. Additionally, during the first clinical evaluation (day 14), patients without insomnia had significantly higher final remission ratios than patients with insomnia (80% [8/10] versus 30.8% [4/13]; χ2=5.79; P=0.016). Conclusion Fluvoxamine improved PSG parameters and ameliorated complaints of insomnia simultaneously during this 8-week study. Moreover, depressed individuals who reported persistent insomnia were at higher risk of remaining depressed by the end of the trial, which might be forecasted by the sleep status on day 14. Trial registration The Effect of Fluvoxamine on Polysomnogram in Depressed Patients with Insomnia; https://clinicaltrials.gov/ct2/show/NCT02442713. Registry identifier: NCT02442713. Registry date: May 13, 2015.